Attention Deficit Hyperactivity DisorderPhase 3NCT01239030

Efficacy and Safety of Methylphenidate HCl ER Capsules in Children and Adolescents With ADHD

A Phase 3 study testing Methylphenidate Hydrochloride Extended Release Capsules in people with Attention Deficit Hyperactivity Disorder and ADHD, run by Rhodes Pharmaceuticals, L.P. at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This multi-center parallel study is designed to study the efficacy and safety of fixed doses of methylphenidate extended release (ER) capsules of four dose levels compared with a placebo group in pediatric patients with Attention Deficit Hyperactivity Disorder (ADHD) who are between 6 and 18 years old. Read more about this study

Who is it for?: Ages 6 to 18 years
Conditions the study is for: Attention Deficit Hyperactivity Disorder, ADHD
What is being tested?: Methylphenidate Hydrochloride Extended Release Capsules
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 230 participants
Where: 16 sitesUnited States
Study dates: Nov 2010to Mar 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Males and females ages 6 up to 18
ADHD diagnosis with ADHD Rating Scale - 4th Edition scores ≥ 90th percentile
In need of treatment for ADHD and able to have 2-day washout from previous medication
Females of child-bearing potential not pregnant and practice birth control
Subject and parent/guardian willing to comply with protocol
Signed consent and assent

Who cannot join

Estimated Full Scale intellectual level below 80 using Wechsler Abbreviated Scale of Intelligence (WASI)
Current primary psychiatric diagnosis of other listed disorders
Chronic medical illnesses: seizure, hypertension, thyroid disease, cardiac, family history of sudden death, glaucoma
Use of psychotropic central nervous system (CNS) meds having effect exceeding 14 days from screening
Planned use of prohibited drugs
Is pregnant or breast-feeding

Show all 12Show fewer

Significant ECG or laboratory abnormalities
Experimental drug or medical device within 30 days prior to screening
Hypersensitivity to methylphenidate
Inability or unwillingness to comply with protocol
Well controlled on current ADHD treatment
Inability to take oral capsules

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

Florida Clinical Research Center, LLC
Bradenton, Florida, 34201
University of Cincinnati College of Medicine/PPSI
Cincinnati, Ohio, 45219
University Hospital Case Medical Center
Cleveland, Ohio, 44106
Department of Psychiatry, Duke University Medical Center
Durham, North Carolina, 27705
University of California, Irvine/Child Development Center
Irvine, California, 92612
Center for Psychiatry and Behavioural Medicine Inc
Las Vegas, Nevada, 89128
Behavioral Clinical Research, Inc.
Lauderhill, Florida, 33319
Clinical Study Centers, LLC
Little Rock, Arkansas, 72205
Precise Research Center
Madison, Mississippi, 39110
Martin Kane, DO
Maitland, Florida, 32751
South Shore Psychiatric Services, PC
Marshfield, Massachusetts, 02050
Synergy Research
National City, California, 91950
CTMG
New Bern, North Carolina, 28562
New York State Psychiatric Institute/Columbia University
New York, New York, 10032
Segal Institute for clinical Research, North Miami Outpatient Clinic
North Miami, Florida, 33161
Wharton Research Center, Inc.
Wharton, Texas, 77488

Other trials in United States

About this study

Official title: A Randomized, Parallel, Double-Blind Efficacy and Safety Study of Biphentin Methylphenidate HCl Extended Release Capsules Compared to Placebo in Children and Adolescents 6 to 18 Years With Attention Deficit Hyperactivity Disorder (ADHD)

Read the detailed description

This is a parallel, randomized, double-blind, multi-center, placebo-controlled, forced dose, phase 3 study to evaluate the safety and efficacy of Biphentin® methylphenidate hydrochloride (HCl) extended release (ER) capsules in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric and adolescent patients aged 6 up to 18 years.

The primary objective was to assess the efficacy of Biphentin compared to placebo, in the clinic setting, as measured by the clinician-administered parent version of the ADHD-RS-IV.

Subjects who met study entry criteria were enrolled in the Double-blind Phase and were randomized to either a fixed dose of Biphentin (!0, 15, 20, or 40 mg/day) or placebo capsule taken daily in the morning for 1 week. Subjects then continued into an Open-label Phase that included dose optimization with doses starting at 10 mg and allowed up to 60 mg. The open-label period following the one double-blind fixed dose week provides additional opportunity for subjects to receive treatment with Biphentin. Extra unscheduled dose optimization visits are allowed as needed for additional dose titration visits during the open-label period.

The safety and tolerability, and efficacy assessments will be conducted throughout the study.

Biphentin® is designed to be a single daily dose alternative to separate doses of immediate release methylphenidate by providing a biphasic plasma profile. It achieves a first Cmax more similar to immediate release methylphenidate.

Conditions: Attention Deficit Hyperactivity Disorder, ADHD
Being tested: Methylphenidate Hydrochloride Extended Release Capsules, Placebo
Keywords: inattention, impulsivity, hyperactivity, ADHD
Medical subject headings: Attention Deficit Disorder with Hyperactivity, Impulsive Behavior, Spasm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Methylphenidate Hydrochloride Extended Release CapsulesDrug
Also called Biphentin
Biphentin Methylphenidate ER Once-A-Day Capsules
PlaceboDrug
Also called Placebo capsules
Placebo capsules

Study groups in NCT01239030
Study group	Role	What they receive
10 mg	Active comparator	Biphentin Methylphenidate Hydrochloride Extended Release Capsules 10 mg Receives: Drug: Methylphenidate Hydrochloride Extended Release Capsules
15 mg	Active comparator	Biphentin Methylphenidate Hydrochloride Extended Release Capsules 15 mg Receives: Drug: Methylphenidate Hydrochloride Extended Release Capsules
20 mg	Active comparator	Biphentin Methylphenidate Hydrochloride Extended Release Capsules 20 mg Receives: Drug: Methylphenidate Hydrochloride Extended Release Capsules
40 mg	Active comparator	Biphentin Methylphenidate Hydrochloride Extended Release Capsules 40 mg Receives: Drug: Methylphenidate Hydrochloride Extended Release Capsules
Placebo	Placebo comparator	Placebo capsules Receives: Drug: Placebo
Methylphenidate HCl ER Capsules (10, 15, 20, 40, 50 or 60 mg)	Experimental	Biphentin Methylphenidate Hydrochloride Extended Release Capsules (10, 15, 20, 40, 50 or 60 mg) - Open Label Phase Receives: Drug: Methylphenidate Hydrochloride Extended Release Capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in ADHD-RS-IV Total Score From Baseline (Visit 2) to the End of the Double-Blind Phase (Visit 3)
Change in ADHD-RS-IV Total Score from Baseline (Visit 2) to end of Double Blind Phase (Visit 3); [Calculations of baseline values (Visit 2) minus end of Double Blind values (Visit 3), higher differences means better outcomes].
Attention Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV): The home version of the ADHD-RS-IV comprising symptoms of ADHD was used. This 18-item scale incorporates each of the ADHD symptoms regardless of assigned subtype. Trained clinicians administered questionnaire to parents. Scoring was based on symptom severity on a 4-point scale: 0=never or rarely, 1=sometimes, 2=often, and 3=very often. The Total Score is the sum of the scores for all 18 items, and could range from 0 (no impairment) to 54 (maximal impairment).
Measured: From baseline (visit 2) to end of of Double-Blind phase (visit 3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010Mar 2012

First posted11 Nov 2010 (estimated)
Study startNov 2010
Primary completionFeb 2012
Study completionMar 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 230 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01239030
Sponsor's protocol ID: RP-BP-EF002
Status last verified: Jan 2023
First submitted: 3 Nov 2010
Last updated: 22 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Wigal SB, Nordbrock E, Adjei AL, Childress A, Kupper RJ, Greenhill L. Efficacy of Methylphenidate Hydrochloride Extended-Release Capsules (Aptensio XR) in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: A Phase III, Randomized, Double-Blind Study. CNS Drugs. 2015 Apr;29(4):331-40. doi: 10.1007/s40263-015-0241-3.
PubMed 25877989

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Parallel, Double-Blind Efficacy and Safety Study of Biphentin Methylphenidate HCl Extended Release Capsules Compared to Placebo in Children and Adolescents 6 to 18 Years With Attention Deficit Hyperactivity Disorder (ADHD)
ClinicalTrials.gov ID: NCT01239030
Acronym / sponsor ID: RP-BP-EF002
Conditions: Attention Deficit Hyperactivity Disorder, ADHD
Keywords: inattention, impulsivity, hyperactivity, ADHD
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 230 participants (actual)
Lead sponsor: Rhodes Pharmaceuticals, L.P.Industry (pharma, biotech, devices)
Study start: Nov 2010
Primary completion: Feb 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 11 Nov 2010 (estimated)
Results: Posted 22 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The primary objective was to assess the efficacy of Biphentin compared to placebo, in the clinic setting, as measured by the clinician-administered parent version of the ADHD-RS-IV.

The safety and tolerability, and efficacy assessments will be conducted throughout the study.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
10 mg	Active comparator	Drug: Methylphenidate Hydrochloride Extended Release CapsulesBiphentin Methylphenidate Hydrochloride Extended Release Capsules 10 mg
15 mg	Active comparator	Drug: Methylphenidate Hydrochloride Extended Release CapsulesBiphentin Methylphenidate Hydrochloride Extended Release Capsules 15 mg
20 mg	Active comparator	Drug: Methylphenidate Hydrochloride Extended Release CapsulesBiphentin Methylphenidate Hydrochloride Extended Release Capsules 20 mg
40 mg	Active comparator	Drug: Methylphenidate Hydrochloride Extended Release CapsulesBiphentin Methylphenidate Hydrochloride Extended Release Capsules 40 mg
Placebo	Placebo comparator	Drug: PlaceboPlacebo capsules
Methylphenidate HCl ER Capsules (10, 15, 20, 40, 50 or 60 mg)	Experimental	Drug: Methylphenidate Hydrochloride Extended Release CapsulesBiphentin Methylphenidate Hydrochloride Extended Release Capsules (10, 15, 20, 40, 50 or 60 mg) - Open Label Phase

Who may qualify

Ages: 6 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

Males and females ages 6 up to 18
ADHD diagnosis with ADHD Rating Scale - 4th Edition scores ≥ 90th percentile
In need of treatment for ADHD and able to have 2-day washout from previous medication
Females of child-bearing potential not pregnant and practice birth control
Subject and parent/guardian willing to comply with protocol

Key exclusion criteria (12 listed)

Estimated Full Scale intellectual level below 80 using Wechsler Abbreviated Scale of Intelligence (WASI)
Current primary psychiatric diagnosis of other listed disorders
Chronic medical illnesses: seizure, hypertension, thyroid disease, cardiac, family history of sudden death, glaucoma
Use of psychotropic central nervous system (CNS) meds having effect exceeding 14 days from screening
Planned use of prohibited drugs

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Methylphenidate Hydrochloride Extended Release CapsulesAlso: BiphentinBiphentin Methylphenidate ER Once-A-Day Capsules	Drug	10 mg, 15 mg, 20 mg, 40 mg, Methylphenidate HCl ER Capsules (10, 15, 20, 40, 50 or 60 mg)
PlaceboAlso: Placebo capsulesPlacebo capsules	Drug	Placebo

Primary outcome

Change in ADHD-RS-IV Total Score From Baseline (Visit 2) to the End of the Double-Blind Phase (Visit 3)
Time frame: From baseline (visit 2) to end of of Double-Blind phase (visit 3)
Change in ADHD-RS-IV Total Score from Baseline (Visit 2) to end of Double Blind Phase (Visit 3); [Calculations of baseline values (Visit 2) minus end of Double Blind values (Visit 3), higher differences means better outcomes]. Attention Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV): The home version of the ADHD-RS-IV comprising symptoms of ADHD was used. This 18-item scale incorporates each of the ADHD symptoms regardless of assigned subtype. Trained clinicians administered questionnaire to parents. Scoring was based on symptom severity on a 4-point scale: 0=never or rarely, 1=sometimes, 2=often, and 3=very often. The Total Score is the sum of the scores for all 18 items, and could range from 0 (no impairment) to 54 (maximal impairment).

Results and safety

Results posted to the registry on 22 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
10 mg (Double-Blind) Then Methylphenidate HCl ER Capsules 10, 15, 20, 40, 50 or 60 mg (Open Label)	49	48
15 mg (Double-Blind) Then Methylphenidate HCl ER Capsules 10, 15, 20, 40, 50 or 60 mg (Open Label)	44	40
20 mg (Double-Blind) Then Methylphenidate HCl ER Capsules 10, 15, 20, 40, 50 or 60 mg (Open Label)	45	44
40 mg (Double Blind) Then Methylphenidate HCl ER Capsules 10, 15, 20, 40, 50 or 60 mg (Open Label)	45	43
Placebo (Double Blind) Then Methylphenidate HCl ER Capsules 10, 15, 20, 40, 50 or 60 mg (Open Label)	47	46

Primary outcome: Change in ADHD-RS-IV Total Score From Baseline (Visit 2) to the End of the Double-Blind Phase (Visit 3)

Time frame: From baseline (visit 2) to end of of Double-Blind phase (visit 3). Mean (Standard Deviation). Unit: units on a scale

Measure	10 mg n = 48	15 mg n = 40	20 mg n = 44	40 mg n = 43	Placebo n = 46
Value	9.3 (8.86)	11.2 (12.06)	12.3 (9.84)	13.2 (10.29)	5.1 (10.29)

10 mg vs 15 mg vs 20 mg vs 40 mg vs Placebo: p = 0.0046, ANCOVA

Population analysed: Efficacy Population (N = 221) comprises subjects who completed ADHD-RS-IV assessments on Day 0 and Day 7.

Adverse events

Time frame: Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Double Blind Phase - Biphentin 10 mg	0 of 49 (0%)	11 of 49 (22.4%)	0 of 49
Double Blind Phase - Biphentin 15 mg	1 of 44 (2.3%)	10 of 44 (22.7%)	0 of 44
Double Blind Phase - Biphentin 20 mg	0 of 45 (0%)	12 of 45 (26.7%)	0 of 45
Double Blind Phase - Biphentin 40 mg	0 of 45 (0%)	11 of 45 (24.4%)	0 of 45
Double Blind Phase - Placebo	0 of 47 (0%)	2 of 47 (4.3%)	0 of 47
Open Label Phase - Biphentin (10, 15, 20, 30, 40, 50 or 60 mg)	1 of 221 (0.5%)	116 of 221 (52.5%)	0 of 221

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25877989Wigal SB, Nordbrock E, Adjei AL, Childress A, Kupper RJ, Greenhill L. Efficacy of Methylphenidate Hydrochloride Extended-Release Capsules (Aptensio XR) in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: A Phase III, Randomized, Double-Blind Study. CNS Drugs. 2015 Apr;29(4):331-40. doi: 10.1007/s40263-015-0241-3.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Wei-wei Chang, Ph.D. study director

NuTec Incorporated

Laurence Greenhill, M.D. principal investigator

New York State Psychiatric Institute / Columbia University

Sharon B. Wigal, Ph.D. principal investigator

University of California, Irvine / Child Development Center

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in ADHD-RS-IV Total Score From Baseline (Visit 2) to the End of the Double-Blind Phase (Visit 3) (time frame: From baseline (visit 2) to end of of Double-Blind phase (visit 3)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01239030, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.